Clinical Research Coordinator

About the role

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF, and regulating agency policies.

Responsibilities

• Study Coordination and Patient Management: Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. Schedule subjects for study visits; meet with them to administer questionnaires, train them on sleep equipment, collect medical history, and perform other study procedures. Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary. Discuss study outcomes with providers to ensure continuity of care. Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement; work to resolve discrepancies and issues. Work with staff to ensure procedures are completed; required data collected at visits; and ensure correct shipping and labeling measures. Coordinate, communicate, and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups. Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence, and study collaboration.

• Data and Equipment Management: Collect data during subject visits; enter data from visits, procedures, and other subject-related participation into databases in a timely manner. Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. Create and maintain comprehensive data sets as requested by the PI. Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analysis in databases. Ensure electrode and sensor recording integrity by troubleshooting common recognizable defects/malfunctions. Manage the maintenance of the polysomnography equipment and at-home sleep/circadian and cognitive testing supplies. Check proper functioning of electrophysiological and testing equipment.

• Staff training: Assist with the training of staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, at-home sleep devices including actigraphy, apnealink, mobile EEG measures, and movement sensors. Attend and actively participate in regular team meetings. Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures. Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments. Help schedule staff time and coordinate staff schedules. Administer sleep assessments and neuropsychological assessments. Maintain subject tracking systems.

• Quality control procedures: Perform periodic quality control procedures to ensure data integrity and accuracy.

• Study Implementation: Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators. Provide quality assurance checks to note if protocols or applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

• Regulatory Responsibilities: Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow-up on IRB submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments. Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.

Qualifications

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.